IGFD Registry: A Patient Registry for Monitoring Long-term Safety and Efficacy of Increlex

This study has been terminated.

(Shortage of Increlex supply)

Sponsor:

Ipsen

ClinicalTrials.gov Identifier:

NCT00747604

First Posted: September 5, 2008

Last Update Posted: April 3, 2015

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.

This project is a retrospective (beginning January 2006) and prospective patient registry program sponsored by Ipsen (formerly Tercica, Inc.). In collaboration with participating health care practitioners, the patient registry program is an observational study monitoring the long-term safety of patients treated with Increlex® (mecasermin [rDNA origin] injection). The IGFD (Increlex® Growth Forum Database) Registry is intended primarily to monitor the safety and efficacy of Increlex replacement therapy in children with growth failure.

Eligible patients will be patients beginning therapy with Increlex® or those previously treated with Increlex.

Biological: mecasermin [rDNA origin] injection

As prescribed by the physician.

Other Name: Increlex®

Detailed Description:

The data collected for a patient will be those that exist in the patient's medical record as part of standard medical care. No additional patient procedures or activities are mandated by this study. The specific data to be collected at each visit and the schedule of data collection are listed in a schedule of assessments.

The collection of safety events is considered essential to the Registry. The website will provide the opportunity to report the occurrence of targeted adverse events (AEs), other important events considered to be related to Increlex administration and serious adverse events (SAEs).

Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:

Child, Adult, Senior

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Sampling Method:

Non-Probability Sample

Study Population

Eligible patients will be patients beginning therapy with Increlex® or those previously treated with Increlex.

Criteria

Inclusion Criteria:

Parents or legally authorized representatives must give signed informed consent before any Registry-related activities are conducted. Assent from the subject should also be obtained where appropriate.

Patients receiving Increlex® by a qualified practitioner may be enrolled

Exclusion Criteria:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00747604